TREATMENT OF CHRONIC HEPATITIS C WITH AMANTADINE HC1

用盐酸金刚烷胺治疗慢性丙型肝炎

• 批准号: 2887514
• 负责人: Jill P Smith
• 金额: $ 12.88万
• 依托单位: PENNSYLVANIA STATE UNIV HERSHEY MED CTR
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-09-30 至 2001-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2887514
• 关键词: amantadine; chronic disease /disorder; clinical research; clinical trials; drug administration rate /duration; drug screening /evaluation; hepatitis C; hepatitis C virus; human subject; human therapy evaluation; liver disorder chemotherapy; quality of life; virus replication

Treatment of hepatitis C has been disappointing with less than one-third achieving a sustained response and most experiencing significant side effects. Although Interferon is the only FDA approved drug for the treatment of hepatitis C in adults, it is not approved for children. A pilot trial was conducted at Pennsylvania State University, College of Medicine in which adult patients with hepatitis C who had failed to respond to interferon were treated with amantadine-HC1 for six months. Serum alanine aminotransferase values decreased in 64 percent of the patients with amantadine therapy compared to intervals without therapy or to interferon therapy. Twenty-seven percent of patient treated with amantadine had normalization of ALT values and loss of hepatitis C virus RNA. Promising results of the pilot study are reason for further investigation. This grant hypothesizes that administration of amantadine-HC1 to patients with chronic hepatitis C will inhibit hepatic inflammation by repressing replication of the hepatitis C virus. We propose to investigate this hypothesis by conducting a prospective randomized double-blind placebo-controlled trial in 100 adult and 50 pediatric patients with chronic hepatitis C. The following specific aims are proposed: 1) Evaluate the efficacy of amantadine as an active antiviral agent for hepatitis C in adult patients who had previously failed therapy with interferon, 2) Study the safety and efficacy of amantadine in children with hepatitis C infection, 3) Evaluate the effects of amantadine on hepatic inflammation and hepatitis C RNA blood levels in naive patients who either decline from interferon therapy or who cannot take interferon for medical reasons, 4) Study response rate and durability of response in patients treated with six versus 12 months of amantadine, and 5) elucidate be effects of amantadine therapy on the patient's quality of lift. These studies are part of one long term goals towards understanding the mechanisms involved in infection and treatment of the hepatitis C virus.

丙型肝炎的治疗一直令人失望，只有不到三分之一 实现持续响应和最重要的方面 效果。尽管干扰素是FDA批准的唯一一种治疗 成人丙型肝炎的治疗，儿童不被批准。 在宾夕法尼亚州立大学学院进行了一项试点试验 对成年丙型肝炎患者未能 干扰素应答用金刚烷胺盐酸盐治疗6个月。 血清丙氨酸氨基转移酶水平下降的百分比 接受金刚烷胺治疗的患者与未接受治疗的患者的比较 或接受干扰素治疗。27%的患者接受了 金刚烷胺使丙氨酸氨基转移酶正常化和丙型肝炎病毒消失 核糖核酸。初步研究的可喜结果是进一步研究的理由。 调查。这项拨款假设政府 盐酸金刚烷胺对慢性丙型肝炎患者肝脏的抑制作用 通过抑制丙型肝炎病毒的复制而引起炎症。我们 建议通过进行前瞻性研究来研究这一假设 100名成人和50名成人的随机双盲安慰剂对照试验 患有慢性丙型肝炎的儿童患者 目的：1)评价金刚烷胺作为一种活性药物的疗效。 抗病毒药物用于既往曾患丙型肝炎的成年患者 干扰素治疗失败，2)研究干扰素的安全性和有效性 金刚烷胺治疗儿童丙型肝炎，3)评价 金刚烷胺对肝脏炎症及丙型肝炎病毒核糖核酸的影响 接受干扰素治疗的幼稚患者的水平下降或 谁因医学原因不能服用干扰素，4)研究应答率 治疗6个月和12个月的患者的反应持久性 5)阐明金刚烷胺治疗对脑血管疾病的影响。 患者的提举质量。这些研究是一个长期项目的一部分。 目标是了解感染和感染的机制 丙型肝炎病毒的治疗。

项目成果

Amantadine therapy for chronic hepatitis C.

金刚烷胺治疗慢性丙型肝炎。

• DOI: 10.1111/j.1525-1497.2004.30057.x
• 发表时间: 2004
• 期刊: Journal of general internal medicine
• 影响因子: 5.7
• 作者: Smith,JillP;Riley3rd,ThomasR;Devenyi,Attila;Bingaman,SandraI;Kunselman,Allen
• 通讯作者: Kunselman,Allen